MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC; MOZ

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Contusion (1787); Muscle Spasm(s) (1966); Rash (2033); Seizures (2063); Numbness (2415); No Code Available (3191)

Event Date 05/12/2001

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment 22-jan-2021: this case concerns a patient who was on treatment with synvisc and reported to have life-threatening 10 minutes of bleeding, muscle cramps and twitching, loss of some body function, numbness in both legs, body contractions, convulsions, seizure like movements, bruises and rash on right hip of right leg; all of which led to disability, required intervention and hospitalization.The information in the case is very limited, therefore, the causality with the device cannot be established.Further, detailed information regarding medical history, clinical course of event, therapy details would aid in comprehensive assessment of the case.

Event Description

10 minutes of bleedings [bleeding], muscle cramps and twitching in right calf of right knee of injection [twitching of limbs], loss of some body function [musculoskeletal disorder nos], numbness in both legs [numbness in leg], body contractions [muscle contractions involuntary], bruises [bruise], convulsions [convulsion], seizure like movement [seizure like phenomena], muscle cramps and twitching in right calf of right knee of injection/full body cramping and spasms [generalised spasm], rash on right hip of right leg of right knee of injection [rash].Case narrative: initial information received on 08-jan-2021 regarding an unsolicited valid serious case received from nurse via health authorities of united states under reference mw5097746.This case involves an unknown age patient who experienced 10 minutes of bleedings, muscle cramps and twitching in right calf of right knee of injection, loss of some body function, numbness in both legs, body contractions, bruises, convulsions, seizure like movement, muscle cramps and twitching in right calf of right knee of injection/full body cramping and spasms and rash on right hip of right leg of right knee of injection, while he/she was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, vaccination(s) and family history were not provided.Concomitant medications included tiotixene (navane); ibuprofen (motrin); and fexofenadine hydrochloride (allegra).Patient had previously received hylan g-f 20, sodium hyaluronate injection.On (b)(6) 2001 (second year), the patient started using hylan g-f 20, sodium hyaluronate intra-articular injection at an unknown dose, frequency (lot: unk, expiration date: unk) for unknown indication.On (b)(6) 2001 (second year 2 injection), after latency of 23 days, patient had muscle cramps (muscle spasm) and twitching in right calf of right knee of injection (muscle twitching) and 10 minutes of bleedings (hemorrhage).Patient had hospitalization.It was reported that still 5 months later patient had full body cramping and spasms (muscle spasm), loss of some body function (musculoskeletal disorder), numbness in both legs (hypoesthesia) (onset: 2001, latency: few months).Patient had a neuro check and "wm (expanded form unknown) spasm", body contractions (muscle contractions involuntary), conscious/seizure like movement (seizure like phenomena) (onset: 2001, latency: few months).Patient had hospitalization twice.Doctor made note of rash on right hip of right leg of right knee of injection (rash) in 2001.On an unknown date in 2001, after unknown latency, patient had rash and bruises (contusion), min's (expanded form not available) spasms (muscle spasm), convulsions (convulsion).All events were assessed as serious as they were life threatening, required intervention and hospitalization, were leading to disability/permanent damage and were medically significant.Action taken: unknown for all events.It was not reported if the patient received a corrective treatment.Outcome: recovered for hemorrhage, unknown for rest of the events product technical complaint (ptc) was initiated with global ptc number (b)(4) on 08-jan-2021 for product.Batch number; unknown.Device not returned.The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa (corrective and preventive action) was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr (non-conformance report) process.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required.Final investigation complete date: 22-jan-2021.Follow up was received on 08-jan-2021 from healthcare professional.Global ptc number was added.Text amended accordingly.Additional information was received on 22-jan-2021 from healthcare professional.Global ptc results added.Text was amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer (Section G): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 11235896
• MDR Text Key: 231957051
• Report Number: 2246315-2021-00041
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/27/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability